The current ART guidelines were issued in 2004 by the NHMRC and updated in 2007 to reflect amendments to the PHCR and RIHE Acts. Please note that Part B of the ART guidelines are currently under review and consequential changes have been required to Part A, the Introduction. Public consultation on draft revision to Part B commenced on 22 July 2015. Click here for further details.

Use of Embryos in Research

The RIHE Act requires that research on certain human embryos may only be conducted under a licence issued by the NHMRC Embryo Licensing Committee. The Licensing Committee must be satisfied that the research proposal has been assessed and approved by a Human Research Ethics Committee acting in compliance with the National Statement on Ethical Conduct in Human Research (2007) (National Statement) and the ART guidelines.

The RIHE Act distinguishes between embryos intended for transfer to a woman to achieve a pregnancy and embryos that have been deemed to be no longer needed in an ART program (‘excess ART embryos’). The PHCR Act and RIHE Act permit research on excess ART embryos, including those that are unsuitable for implantation, and embryos created by means other than by fertilisation of a human egg and human sperm. Consent from the donor must also be sought prior to use of excess ART embryos for research.

For any licensable activity the number of excess ART embryos, other embryos or human eggs should be restricted to that likely to be necessary to achieve the goals of the activity. Research proposals involving human embryos must not include any practices prohibited by the legislation.

The ART guidelines underpin the regulation of ART practice within Australia. RTAC Accreditation is the basis of a nationally consistent approach for overseeing ART clinical practice. RTAC accreditation requires ART treatment centres to comply with government laws and guidelines concerning the practice of ART. The ART guidelines are included in this requirement.

Sex Selection through Pre-implantation Genetic Diagnosis (PGD)

The ART guidelines restrict the use of PGD for sex selection in Australia. The guidelines state that sex selection (by whatever means) should not be undertaken except to reduce the risk of transmission of a serious genetic condition (see sections 11 and 12 of the ART guidelines).